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ISRCTN
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ISRCTN21562211
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DOI
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10.1186/ISRCTN21562211
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The effect of intranasal sodium cromoglycate on symptoms of suspected acute viral upper respiratory tract infection (URTI) in children
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Scientific title
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Acronym
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SAVIT Study
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Serial number at source
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G9900236
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Study hypothesis
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The trial is designed to answer the question; "In children presenting in general practice with suspected acute viral upper respiratory tract infection of less than 36 h duration, does treatment with intranasal sodium cromoglycate improve symptoms more than placebo?"
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Primary care
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Participants - inclusion criteria
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Children aged from 6 months to 6 years with suspected acute viral URTI for less than 36 h
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Participants - exclusion criteria
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Children with: a history of having taken cromolyns or steroids within the previous week; carers who are incapable of giving informed consent or unable to keep symptom diaries; an established complication requiring immediate hospitalisation, or for whom the clinician plans to prescribe antibiotics at the first consultation.
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Anticipated start date
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01/09/1999
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Anticipated end date
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31/08/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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300
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Interventions
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300 children will be randomised to receive either normal saline nose spray or sodium cromoglycate 4% nose spray every 2 h (during waking hours) for the first 2 days, and every 4 h for a further 5 days or until quite well.
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Primary outcome measure(s)
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CARIFS Scale Score
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12090980
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Contact name
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Dr
Christopher C
Butler
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Address
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Department of General Practice
University of Wales College of Medicine Health Centre Maelfa
Llanedeyrn
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City/town
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Cardiff
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Zip/Postcode
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CF23 9PN
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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13/09/2007
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Date ISRCTN assigned
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23/10/2000
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